WO2017036207A1 - 植入医疗器械 - Google Patents

植入医疗器械 Download PDF

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Publication number
WO2017036207A1
WO2017036207A1 PCT/CN2016/084287 CN2016084287W WO2017036207A1 WO 2017036207 A1 WO2017036207 A1 WO 2017036207A1 CN 2016084287 W CN2016084287 W CN 2016084287W WO 2017036207 A1 WO2017036207 A1 WO 2017036207A1
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WIPO (PCT)
Prior art keywords
medical device
anchor
implantable medical
anchors
waveform
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PCT/CN2016/084287
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English (en)
French (fr)
Inventor
肖本好
王逸斐
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先健科技(深圳)有限公司
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Publication of WO2017036207A1 publication Critical patent/WO2017036207A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes

Definitions

  • the present invention relates to medical devices, and more particularly to an implanted medical device.
  • Implanted medical devices especially luminal implanted medical devices, such as luminal stents, filters, aortic valves, etc., are generally fixed in the lumen by inflation with a radial support force in close contact with the lumen wall.
  • at least one round of bare stent can be placed in the instrument to enhance the friction between the instrument and the lumen wall.
  • an anchor thorn can also be arranged on the bare stent, and the anchor thorn penetrates the wall of the lumen to firmly anchor the instrument in the lumen.
  • the anchor thorn can be integrally cut while cutting the bare stent pattern.
  • the preparation process of the anchor thorn is relatively simple and easy to implement, but the obtained anchor thorn fatigue resistance is poor.
  • the anchor is formed by separate cutting and is fixed to the wire by mechanical connection (for example, welding, riveting, etc.).
  • the diameter of the wire generally used to prepare the bare stent segment is about 0.1 to 0.8 mm, that is, the contact area with the anchor thorn is very small, and the process of welding or riveting is relatively complicated and difficult, and the performance of the device is And the precision requirements are high, and there is also the risk of the anchor thorns falling off the wire.
  • the welding or riveting process is also easy to cause damage to the small diameter long wire itself, further increasing the risk of anchor piercing.
  • the technical problem to be solved by the present invention is to provide an implanted medical device having an anchor thorn for the defect that the fatigue resistance of the anchor thorn on the bare stent in the prior art is poor and the anchor thorn is easily detached from the bare stent.
  • the technical solution adopted by the present invention to solve the technical problem thereof is to provide an implanted medical device comprising at least one closed bare bracket and at least one anchor thorn, the bare bracket comprising a plurality of waveform segments connected end to end. At least one end of at least one of the plurality of waveform segments is bent to form the anchor.
  • the end portion of the waveform segment is bent at an angle of 10 to 170 degrees.
  • the implanted medical device has a plurality of anchors, and an axial spacing between the starting ends of at least two of the plurality of anchors is greater than zero.
  • the stent includes from 2 to 8 of the waveform segments.
  • the waveform segment comprises at least one peak, at least one trough adjacent to the crest, and a bar connecting the crests adjacent to the crest.
  • the plurality of waveform segments are connected end to end by cannulated or welded or hot melted or kinked.
  • the bare stent has a trapezoidal cross-section, and the cross-sectional area of the proximal end section of the bare stent is larger than the cross-sectional area of the distal diameter section of the bare stent.
  • the trapezoid has an equivalent taper angle of 10 to 90°.
  • FIG. 1 is a schematic structural view of a lumen stent according to an embodiment of the present invention.
  • FIG. 2 is a schematic structural view of a bare bracket according to an embodiment of the present invention.
  • Figure 3 is a schematic view showing the connection of the waveform segments of the bare stent of Figure 2;
  • Figure 4 is a schematic view showing the connection of the waveform segments of the bare bracket of Figure 2;
  • Figure 6 is a plan view of Figure 2;
  • FIG. 7 is a schematic structural view of a waveform segment of the bare stent of FIG. 2;
  • Figure 8 is a schematic structural view of a waveform segment of the bare stent of Figure 2;
  • FIG. 10 is a schematic structural view of a waveform segment of the bare stent of FIG. 2.
  • FIG. 10 is a schematic structural view of a waveform segment of the bare stent of FIG. 2.
  • the lumen stent 1 may be an abdominal aortic stent, a thoracic aortic stent, a radial artery stent, etc., having a radially compressed state and a radially expanded state, and the lumen stent 1 in a radially compressed state is disposed in the delivery device during use. And transported to the lesion position of the human lumen through the delivery device, and after being released, it is expanded by self-expansion or balloon to a radially expanded state to be in close contact with the wall of the human body lumen, thereby being fixed in the lumen of the human body by the radial support force.
  • the stent graft segment 12 includes a metal support structure and a coating covering the metal support structure (not directly shown), and the coating may be The PET film or the ePTFE film is coated with a metal support structure by heat setting; or the film may be a polyester cloth film, and the metal support structure is covered by stitching.
  • the bare stent 11 and the body lumen wall have relatively large frictional force, which can improve the adherence performance of the lumen stent 1, and reduce the lumen stent 1 in the human lumen. The risk of position.
  • the closed bare bracket 11 includes a plurality of independent waveform segments 111, and the plurality of waveform segments 111 are connected end to end to form the closed bare bracket 11.
  • the number of waveform segments 111 is at least two, and the number of suitable waveform segments 111 can be selected according to the diameter of the lumen stent 1.
  • the diameter of the bare stent 11 is relatively Larger, 5 to 8 waveform segments 111 can be selected; and for the radial artery stent, the diameter of the bare stent 11 is relatively small, and a smaller number of waveform segments 111 can be selected, for example, 3 or 4 waveform segments 111. .
  • the six waveform segments 111 are shown by way of example in the figures, but this example is not limiting of the invention, and one of ordinary skill in the art can select the appropriate number of waveform segments 111 as desired.
  • the waveform segment 111 includes at least one crest 113, at least one trough 114 adjacent to the crest 113, and a shank 115 connecting the crests 114 adjacent to the crest 113.
  • the waveform segment 111 shown in FIG. 2 includes a peak 113 and a valley 114.
  • a single waveform segment 111 may include a plurality of peaks 113 and/or Or multiple troughs 114 and vice versa.
  • the closed bare bracket 11 formed by the two waveform segments 111 connected in series may have a Z-shaped wave, a U-shaped wave or a triangular wave.
  • the adjacent wave segments 111a and 111b can be anchored and fastened by a sleeve 116; see Fig. 4, the adjacent wave segments 111a and 111b can be fastened by welding or hot melt. Connecting, and forming a weld zone or hot melt zone 117 at the contact portion between the wave segments 111a and 111b, one of ordinary skill in the art can tighten the connection waveform segment 111 in any suitable manner, for example, by kinking I will not repeat them here.
  • the anchor thorn 112 is formed by bending one end of the wave segment 111, and is not an anchor thorn formed by bending a partial cut portion in the cutting bracket, and correspondingly there is no local region force, so the anchor thorn 112 has good rigidity and The bending strength is not easy to fall off from the wave segment 111, the stability is good, and the fatigue tolerance is good, and it is not easy to bend and break when subjected to biomechanical action in the human lumen.
  • a portion of the wave segment 111 can be selectively bent as needed to form the anchor thorn 112 having a desired length L, which is not limited to cutting the tube and cutting the pattern as the cutting anchor is.
  • the contact area of the waveform segments 111 can be used when connected by two or two, and is mechanically connected (for example, the anchor of the casing 116).
  • the connection stability is high at the same time, and the waveform segment 111 material itself is not easily damaged.
  • the anchor thorn 112 shown in FIG. 5 is formed by bending the end of the rod body 115 of the wave segment 111, and under the condition that the anchor thorn 112 is ensured to be directed outside the cavity of the bare bracket 11, the anchor thorn 112 can be pointed In a plurality of bending directions, the inner wall of the human lumen is smooth and the shape is regular.
  • the anchor 112 is located in the axial section of the bare stent 11 (through the axial section of the central longitudinal axis of the bare stent 11), the lumen stent 1 Better adherence performance can be achieved. Referring to the example of FIG.
  • the end portion of the waveform segment 111 is bent at a predetermined bending angle ⁇ to form an anchor thorn 112, which can be defined as the angle between the anchor thorn 112 and the rod 115 connected to the anchor thorn 112.
  • ⁇ is 10 to 170°.
  • the anchor thorns 112 have different bending directions at the same bending angle ⁇ , for example, within or offset from the axial section of the bare bracket 11.
  • ⁇ is an obtuse angle, which may be 90-170°, and the anchor thorn 112 is directed to the distal end of the bare stent 11; see Fig.
  • ⁇ is an acute angle, which may be 10 to 90°, and the anchor thorn 112 is directed to the bare stent 11 end.
  • the size of ⁇ can be selected according to the actual type of lumen support 1, but also the length L of the anchor thorn 112 can be adaptively selected, for example, the size of L is selected according to the value of ⁇ and/or the thickness of the wall of the human body at the implantation site.
  • the bare bracket 11 includes a plurality of anchors 112
  • the lengths of the anchors 112 may not all be the same, and/or the bending angles of the anchors 112 may not be all the same.
  • the difference setting is applied to the twisted human lumen, which can improve the stability of the implant or improve the success rate of the anchor 112 into the wall of the human body.
  • the axial section of the bare stent 11 is trapezoidal, and the cross-sectional area of the proximal diameter section 119a (the radial section perpendicular to the central longitudinal axis of the bare stent 11) is larger than the sectional area of the distal section 119b; the equivalent of the trapezoid
  • the taper angle (that is, the angle between the extension lines of the two oblique sides of the trapezoid) may be 10 to 90 degrees.
  • the bare stent 11 has an initial tendency to expand radially outward, and is implanted into the lumen of the human body and has a large radially outward expansion force after being radially deployed, thereby effectively causing the anchor thorn 112 to penetrate the human lumen. wall.
  • the bare bracket 11 has a central longitudinal axis 120 and includes a plurality of anchors, the starting end of each anchor, i.e., the bending point of the shaft, having a projection point on the central longitudinal axis 120, for example, an anchor 112a
  • the projection point of the starting end on the central longitudinal axis is point A
  • the projection point of the starting end of the anchor thorn 112b on the central longitudinal axis is point B
  • the spacing between the point A and the point B can be expressed as the anchor thorn 112a and The axial spacing between the starting ends of 112b.
  • the anchor thorn and the basic structural unit (waveform segmentation) forming the bare bracket are integrated, and specifically, the anchor thorn is formed by bending one end of the wave segment, so that the fatigue withstand capability is better and difficult. Fall off or break off the waveform segment.
  • the length of the anchor is no longer limited by the cutting tube and the cutting pattern in the cutting process, and the length range selectable is large.
  • the structure avoids that the basic structural unit of the single anchor and the bare bracket needs to be connected by mechanical fastening such as welding or riveting, but the waveform segment and the waveform segment are fixed to each other, and the optional solid connection is selected.
  • the range (contact area and contact length) is relatively large. For example, a large contact area can be realized by a large contact length, so that the stability of the connection is high, and the process is simple, and the material of the waveform segmentation itself is less affected. .

Abstract

一种植入医疗器械（1），包括至少一圈闭合的裸支架（11）和至少一个锚刺（112）。裸支架（11）包括多个首尾相连的波形分段（111）。多个波形分段（111）中的至少一个波形分段（111）的至少一个端部弯折形成锚刺（112）。由于锚刺（112）是波形分段（111）的一部分，因此该锚刺（112）具有良好的刚性和弯折强度，不会从波形分段（111）上脱落，稳定性好，且疲劳耐受力较好，在人体管腔内受生物力学作用时不易弯折断裂。由于波形分段（111）与波形分段（111）之间彼此固连，可选择的固连接触范围受限制较小，可通过较大的接触长度来实现较大的接触面积，因此固连稳定性高，且工艺简单，对波形分段的材料本身影响较小。

Description

植入医疗器械
【技术领域】
本发明涉及医疗器械，尤其涉及一种植入医疗器械。
【背景技术】
植入医疗器械，尤其是管腔植入医疗器械，例如管腔支架、滤器、主动脉瓣膜等，膨胀后一般通过径向支撑力与管腔壁紧贴而固定于管腔中。为避免器械移位，可在器械中设置至少一圈裸支架，以增强器械与管腔壁之间的摩擦力。进一步地，还可在裸支架上设置锚刺，通过锚刺刺入管腔壁使器械稳固锚定于管腔内。
对于由金属制成的器械，若裸支架通过金属管材切割形成，则可在切割裸支架花纹的同时一体切割形成锚刺。该锚刺的制备工艺相对简单，易于实现，但是制得的锚刺疲劳耐受性较差。若裸支架通过金属丝热定型形成，则锚刺需单独切割形成，并通过机械连接（例如焊接、铆接等）固定于金属丝上。然而，一般用来制备裸支架段的金属丝的直径大约为0.1～0.8mm，即与锚刺的接触面积非常小，由此进行焊接或铆接的工艺过程相对复杂、难度高，对设备的性能和精度要求高，同时还会存在锚刺从金属丝脱落的风险。并且，焊接或铆接工艺还易对小径长金属丝本身造成伤害，进一步提高了锚刺脱落的风险。
【发明内容】
本发明要解决的技术问题在于，针对现有技术中裸支架上锚刺的疲劳耐受能力差以及锚刺易于从裸支架脱落的缺陷，提供一种具有锚刺的植入医疗器械。
本发明解决其技术问题所采用的技术方案是：提供了一种植入医疗器械，包括至少一圈闭合的裸支架和至少一个锚刺，所述裸支架包括多个首尾相连的波形分段，所述多个波形分段中的至少一个波形分段的至少一个端部弯折形成所述锚刺。
在依据本发明实施例的植入医疗器械中，所述波形分段的端部弯折角度为10～170°。
在依据本发明实施例的植入医疗器械中，所述锚刺具有尖端。
在依据本发明实施例的植入医疗器械中，所述植入医疗器械具有多个锚刺，所述多个锚刺中的至少两个锚刺的起始端之间的轴向间距大于零。
在依据本发明实施例的植入医疗器械中，所述植入医疗器械具有多个锚刺，所述多个锚刺中的至少一个锚刺的长度不同于其它锚刺的长度、或者所述多个锚刺中的至少一个锚刺所在的波形分段的端部弯折角度不同于其它锚刺所在的波形分段的端部弯折角度、或者所述多个锚刺中的至少一个锚刺的长度以及该锚刺所在的波形分段的端部弯折角度均分别不同于其它锚刺的长度以及所述其它锚刺所在的波形分段的端部弯折角度。
在依据本发明实施例的植入医疗器械中，所述支架包括2～8个所述波形分段。
在依据本发明实施例的植入医疗器械中，所述波形分段包括至少一个波峰、至少一个与所述波峰相邻的波谷、以及连接所述波峰与所述波峰相邻的波谷的杆体。
在依据本发明实施例的植入医疗器械中，所述多个波形分段通过套管锚压或焊接或热熔或扭结两两首尾相连。
在依据本发明实施例的植入医疗器械中，所述裸支架的轴截面为梯形，所述裸支架的近端径截面的截面积大于所述裸支架的远端径截面的截面积。
在依据本发明实施例的植入医疗器械中，所述梯形的等效锥角为10～90°。
本发明中的锚刺为波形分段的一部分，因此该锚刺具有良好的刚性和弯折强度，不会从波形分段上脱落，稳定性好，且疲劳耐受力较好，在人体管腔内受生物力学作用时不易弯折断裂。且波形分段与波形分段之间彼此固连，可选择的固连接触范围（接触面积以及接触长度）受限制较小，可通过较大的接触长度来实现较大的接触面积，因此固连稳定性高，且工艺简单，对波形分段的材料本身影响较小。
【附图说明】
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明实施例的管腔支架的结构示意图；
图2是本发明实施例的裸支架的结构示意图；
图3是图2中裸支架的波形分段的连接示意图；
图4是图2中裸支架的波形分段的连接示意图；
图5是图2中裸支架的波形分段的局部示意图；
图6是图2的俯视图；
图7是图2中裸支架的波形分段的结构示意图；
图8是图2中裸支架的波形分段的结构示意图；
图9是图2中裸支架的波形分段的结构示意图；
图10是图2中裸支架的波形分段的结构示意图。
【具体实施方式】
本发明提供的植入医疗器械包括但不限于管腔支架、管腔滤器、或心脏瓣膜。为了对本发明的技术特征、目的和效果有更加清楚的理解，现以管腔支架为例，对照附图详细说明本发明的具体实施方式，应当知晓，此处的管腔支架仅用作举例，并不是对本发明的限制，本领域的普通技术人员不需要付出创造性的劳动即可将本发明的教导用于上述其它植入医疗器械。为描述方便，通过血流方向定义管腔支架的近端和远端，即定义血流从管腔支架的近端流向远端。
如图1所示，一种管腔支架1包括至少一圈闭合裸支架11。对于隔离动脉瘤的管腔支架1，该管腔支架1可在轴向上依次包括至少一圈闭合裸支架11、以及覆膜支架段12；对于适用于血管狭窄的管腔支架1，其可仅包括多圈闭合裸支架11，不包括覆膜支架段。闭合裸支架11形成的腔体、或者闭合裸支架11与覆膜支架段12共同形成的腔体在植入人体后成为新的血流通道。该管腔支架1可以是腹主动脉支架、胸主动脉支架、髂动脉支架等，具有径向压缩状态和径向扩展状态，使用中将处于径向压缩状态的管腔支架1设于输送装置中并经由输送装置输送至人体管腔的病变位置，释放后通过自膨胀或球囊扩张至径向扩展状态，以紧贴人体管腔壁，从而通过径向支撑力固定于人体管腔中。
可采用现有的、任意适合的结构作为覆膜支架段12，例如，覆膜支架段12包括金属支撑结构以及包覆该金属支撑结构的覆膜（图中未直接显示），覆膜可以是PET膜或ePTFE膜，通过热定型包覆金属支撑结构；或者覆膜可以是涤纶布膜，通过缝合的方式包覆金属支撑结构。相比于覆膜支架段12，裸支架11与人体管腔壁之间具有相对较大的摩擦力，可提高管腔支架1的贴壁性能，减少了管腔支架1在人体管腔内移位的风险。
参见图2，闭合裸支架11包括多个独立的波形分段111，多个波形分段111两两首尾相连形成该闭合裸支架11。波形分段111的数量最少是2个，根据管腔支架1的径长可选择合适的波形分段111的数量，例如，对于腹主动脉支架或胸主动脉支架，裸支架11的径长相对较大，可选择5～8个波形分段111；而对于髂动脉支架，裸支架11的径长相对较小，可选择较少数量的波形分段111，例如3或4个波形分段111。图中示例地显示了6个波形分段111，但是该示例并不是对本发明的限制，本领域的普通技术人员可根据需要选择合适数量的波形分段111。
波形分段111包括至少一个波峰113、至少一个与该波峰113相邻的波谷114、以及连接波峰113与该波峰113相邻的波谷114的杆体115。图2示出的波形分段111包括一个波峰113和一个波谷114，当然，若裸支架11包括数量相对较少的波形分段111，单个波形分段111中则可包括多个波峰113和/或多个波谷114，反之亦然。由此，由上述波形分段111两两相连形成的闭合裸支架11可以具有Z形波、U形波或三角波。
参见图3，相邻的波形分段111a和111b之间可通过套管116锚压紧固连接；参见图4，相邻的波形分段111a和111b之间可通过焊接或热熔方式紧固连接，并在波形分段111a和111b之间的接触部分形成焊接区域或热熔区域117，本领域的普通技术人员可采用任意适合的方式紧固连接波形分段111，例如还可通过扭结连接，此处不再一一赘述。
参见图2和5，在上述多个波形分段111中，至少有一个波形分段111的至少一个端部弯折形成锚刺112，该锚刺112指向裸支架11围合形成的腔体之外，当管腔支架1植入人体管腔后，该锚刺112可刺入管腔壁而使得管腔支架1稳固设于人体管腔中。该锚刺112还可具有尖端（图中未示出），方便刺入人体管腔壁。该锚刺112通过弯折波形分段111的一端形成，因此与波形分段111为一体结构。
上述锚刺112由波形分段111的一端弯折形成，而并非切割支架中的局部切割部分弯折形成的锚刺，对应地不存在局部区域受力，因此该锚刺112具有良好的刚性和弯折强度，不易从波形分段111上脱落，稳定性好，且疲劳耐受力较好，在人体管腔内受生物力学作用时不易弯折断裂。与此同时，可根据需要选择性地弯折波形分段111的一部分来形成具有需要长度L的锚刺112，不会如切割锚刺一般受限于切割管材以及切割花纹。另外，相比于单个锚刺与裸支架相连时可采用的接触面积，波形分段111之间两两相连时可采用的接触面积较大，在采用机械连接方式（例如套管116锚固）固连时连接稳定性高，且不易损伤波形分段111材料本身。
具体地，图5中示出的锚刺112由波形分段111的杆体115的端部弯折形成，在确保锚刺112指向裸支架11的腔体之外的条件下，锚刺112可指向多个弯折方向，人体管腔内壁光滑且形状规则的理想情况下，当锚刺112位于裸支架11的轴截面（通过裸支架11的中心纵轴的轴向截面）内时管腔支架1可达到较佳贴壁性能。参见图6的示例，从裸支架11的俯视图可以看出，锚刺112位于裸支架11的一个轴截面118中，此时锚刺112刺入人体管腔壁的长度占锚刺112总长度L的比例最大，裸支架11的贴壁性能较佳。当人体管腔的内壁形状不规则时，偏离轴截面的裸支架11也可达到最佳锚定效果。
参见图5，波形分段111的端部弯折预定的弯折角度θ形成锚刺112，可定义该弯折角度θ为锚刺112与和该锚刺112相连的杆体115之间的夹角，θ为10～170°，如以上所述可知，同一弯折角度θ下锚刺112具有不同弯折方向，例如位于裸支架11的轴截面以内或偏离该轴截面。参见图7，θ为钝角，可以是90～170°，锚刺112指向裸支架11的远端；参见图8，θ为锐角，可以是10～90°，锚刺112指向裸支架11的近端。不仅可根据实际的管腔支架1类型选择θ的大小，还可适应地选择锚刺112长度L的大小，例如根据θ值和/或植入处的人体管腔壁的厚度选择L的大小。在本发明的具体实施方式中，当裸支架11包括多个锚刺112时，锚刺112的长度可以不全部相同、和/或形成锚刺112的弯折角度也可以不全部相同，这种差异设置适用于扭曲的人体管腔，可提高植入稳定性能，或者提高锚刺112刺入人体管腔壁的成功率。
参见图9，裸支架11的轴截面为梯形，近端径截面119a（与裸支架11的中心纵轴垂直的径向截面）的截面积大于远端截面119b的截面积；该梯形的等效锥角（即梯形的两条斜边的延长线的夹角）可以为10～90°。图中裸支架11具有初始的向径向外侧扩张的趋势，植入人体管腔并径向展开后具有较大的向径向外侧扩张的力，从而能有效促使锚刺112刺入人体管腔壁。
参见图10，裸支架11具有中心纵轴120，并包括多个锚刺，每个锚刺的起始端即杆体的弯折点，在中心纵轴120上均具有投影点，例如，锚刺112a的起始端在中心纵轴上的投影点为点A，锚刺112b的起始端在中心纵轴上的投影点为点B，点A与点B之间的间距则可表示为锚刺112a与112b的起始端之间的轴向间距。多个锚刺的起始端在中心纵轴120上的投影可以重合，即所有的锚刺的起始端位于裸支架11的同一径截面上。或者，多个锚刺中至少有两个锚刺，其起始端在中心纵轴上的投影具有大于零的间距，即两个投影在中心纵轴120上不重合，例如锚刺112a与112b。采用该设置，可使得不同的锚刺在不同的轴向位置刺入人体管腔壁，对于扭曲的人体管腔，管腔支架1受力不均匀的情况下，该设置可以提高锚刺112刺入人体管腔壁的成功率，并提高刺入深度。
综上，本发明中锚刺与形成裸支架的基本结构单元（波形分段）为一体结构，具体地，该锚刺由波形分段的一端弯折形成，因此疲劳耐受能力较佳，不易从波形分段上脱落或折断。不仅如此，锚刺的长度不再受限于切割工艺中的切割管材和切割花纹，可选择的长度范围较大。另外，该结构避免了单个锚刺与裸支架的基本结构单元需要采用诸如焊接或铆接等机械固接法相连，而是波形分段与波形分段之间彼此固连，可选择的固连接触范围（接触面积以及接触长度）相对较大，例如，可通过较大的接触长度来实现较大的接触面积，因此固连稳定性高，且工艺简单，对波形分段的材料本身影响较小。

Claims (10)

  1. 一种植入医疗器械，包括至少一圈闭合的裸支架和至少一个锚刺，其特征在于，所述裸支架包括多个首尾相连的波形分段，所述多个波形分段中的至少一个波形分段的至少一个端部弯折形成所述锚刺。
  2. 根据权利要求1所述的植入医疗器械，其特征在于，所述波形分段的端部弯折角度为10～170°。
  3. 根据权利要求1所述的植入医疗器械，其特征在于，所述锚刺具有尖端。
  4. 根据权利要求1所述的植入医疗器械，其特征在于，所述植入医疗器械具有多个锚刺，所述多个锚刺中的至少两个锚刺的起始端之间的轴向间距大于零。
  5. 根据权利要求1所述的植入医疗器械，其特征在于，所述植入医疗器械具有多个锚刺，所述多个锚刺中的至少一个锚刺的长度不同于其它锚刺的长度、或者所述多个锚刺中的至少一个锚刺所在的波形分段的端部弯折角度不同于其它锚刺所在的波形分段的端部弯折角度、或者所述多个锚刺中的至少一个锚刺的长度以及该锚刺所在的波形分段的端部弯折角度均分别不同于其它锚刺的长度以及所述其它锚刺所在的波形分段的端部弯折角度。
  6. 根据权利要求1所述的植入医疗器械，其特征在于，所述支架包括2～8个所述波形分段。
  7. 根据权利要求1所述的植入医疗器械，其特征在于，所述波形分段包括至少一个波峰、至少一个与所述波峰相邻的波谷、以及连接所述波峰与所述波峰相邻的波谷的杆体。
  8. 根据权利要求1所述的植入医疗器械，其特征在于，所述多个波形分段通过套管锚压或焊接或热熔或扭结两两首尾相连。
  9. 根据权利要求1所述的植入医疗器械，其特征在于，所述裸支架的轴截面为梯形，所述裸支架的近端径截面的截面积大于所述裸支架的远端径截面的截面积。
  10. 根据权利要求9所述的植入医疗器械，其特征在于，所述梯形的等效锥角为10～90°。
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3510976A1 (en) * 2018-01-11 2019-07-17 Cook Medical Technologies LLC Barbed wire stent

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105167892A (zh) * 2015-09-02 2015-12-23 先健科技(深圳)有限公司 植入医疗器械
CN109199658B (zh) * 2017-07-03 2024-03-29 深圳市科奕顿生物医疗科技有限公司 一种自膨式管腔支架及其制作方法
CN109199657B (zh) * 2017-07-03 2024-04-30 深圳市科奕顿生物医疗科技有限公司 一种自膨式分叉管腔支架及其制作方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101360466A (zh) * 2005-10-20 2009-02-04 阿普特斯内系统公司 包括假体组件的用于假体输送和植入的装置、系统和方法
US20090171442A1 (en) * 2007-12-27 2009-07-02 Cook Incorporated Z-stent with incorporated barbs
CN202801864U (zh) * 2012-09-21 2013-03-20 沛嘉医疗科技（上海）有限公司 人工心脏瓣膜
US20140194805A1 (en) * 2002-12-02 2014-07-10 Gi Dynamics, Inc. Anti-Obesity Devices
CN104287870A (zh) * 2014-10-10 2015-01-21 先健科技(深圳)有限公司 管腔支架
CN105167892A (zh) * 2015-09-02 2015-12-23 先健科技(深圳)有限公司 植入医疗器械
CN205007080U (zh) * 2015-09-02 2016-02-03 先健科技(深圳)有限公司 植入医疗器械

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6344056B1 (en) * 1999-12-29 2002-02-05 Edwards Lifesciences Corp. Vascular grafts for bridging a vessel side branch
US7147661B2 (en) * 2001-12-20 2006-12-12 Boston Scientific Santa Rosa Corp. Radially expandable stent
US20040117004A1 (en) * 2002-05-16 2004-06-17 Osborne Thomas A. Stent and method of forming a stent with integral barbs
US20090149946A1 (en) * 2007-12-05 2009-06-11 Cook Incorporated Stent having at least one barb and methods of manufacture
CN103598929B (zh) * 2013-11-28 2016-04-20 先健科技(深圳)有限公司 胸主动脉覆膜支架
CN104799974A (zh) * 2015-04-20 2015-07-29 上海纽脉医疗科技有限公司 一种带倒刺的介入式人工心脏瓣膜的支架及其制备方法

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140194805A1 (en) * 2002-12-02 2014-07-10 Gi Dynamics, Inc. Anti-Obesity Devices
CN101360466A (zh) * 2005-10-20 2009-02-04 阿普特斯内系统公司 包括假体组件的用于假体输送和植入的装置、系统和方法
US20090171442A1 (en) * 2007-12-27 2009-07-02 Cook Incorporated Z-stent with incorporated barbs
CN202801864U (zh) * 2012-09-21 2013-03-20 沛嘉医疗科技（上海）有限公司 人工心脏瓣膜
CN104287870A (zh) * 2014-10-10 2015-01-21 先健科技(深圳)有限公司 管腔支架
CN105167892A (zh) * 2015-09-02 2015-12-23 先健科技(深圳)有限公司 植入医疗器械
CN205007080U (zh) * 2015-09-02 2016-02-03 先健科技(深圳)有限公司 植入医疗器械

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3510976A1 (en) * 2018-01-11 2019-07-17 Cook Medical Technologies LLC Barbed wire stent
US10959864B2 (en) 2018-01-11 2021-03-30 Cook Medical Technologies Llc Barbed wire stent

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